This proposal seeks funding for a Planning Grant to establish a Stage 1 Dental, Oral and Craniofacial Tissue Regeneration Consortium (DOCTRC) Resource Center (RC) at the University of Virginia (UVA). The interdisciplinary UVA DOCTRC will be focused on clinical translation of a Tissue Engineered Muscle Repair (TEMR) technology platform for regeneration and reconstruction of craniofacial muscle. We will target treatment of craniofacial injuries, diseases, disorders or malformations for which current therapies are inadequate to restore function and/or appearance due to a lack of viable native muscle tissue. The overarching goal is to leverage the unique environment at UVA to optimize and expand the clinical applicability of the TEMR technology platform for craniofacial indications. Specifically, e shall: Aim 1. Create a Regenerative Medicine Technology Development Center (RM-TDC). The RM-TDC will be the critical integrative hub of the UVA DOCTRC RC. The RM-TDC will consist of four distinct components, as follows: (a) Biologically Relevant Animal Models and Metrics Core, (b) Imaging and Computer Modeling Core, (c) Clinical Translation Infrastructure and Process Core, (d) Translational Expert Panel (TEP). The goal of this Aim is to overcome the major roadblocks in the development and clinical implementation of regenerative medicine technologies. Aim 2. Ensure continuous effective communication and synergistic integration among the 4 components of the RM-TDC, as well as the coordination of the activities of the RM-TDC with the Discovery and Translation Navigator (DTN), Commercial Partners and the External Advisory Board (EAB). The goal of this Aim is to boost the rate and efficiency of delivery of regenerative medicine technologies to patients in need. Aim 3. Create Interdisciplinary Translational Projects (ITPs) that address important unmet medical needs relevant to the DOCTRC mission. We have initially identified two ITPs suitable for our TEMR technology platform, and for which we already possess relevant clinical expertise; they are cleft lip and cleft palate, respectively. The selection of additional ITPs will follow a rigorous evaluaton process. The goal of this Aim is to ensure that the ITPs have the appropriate expertise and resources required for expedited clinical translation, and moreover, that operation of the ITPs is aligned and integrated with all other components of the DOCTRC. We will deliver: 1) standardized models and metrics for rapid preclinical technology evaluation, 2) imaging modalities and computational models for improved TEMR technology selection and enhanced functional muscle recovery in vivo, 3) correct alignment of the interdisciplinary expertise required for improved cost- structure and efficiency of clinical translation in an academic setting This approach will shorten time lines from proof-of-concept to clinical studies, and ensure the availability of a TEMR technology platform with more widespread clinical utility for treatment of a spectrum of craniofacial defects, and related injuries.